AnesthesiaNCT02439606
GlideRite® Rigid Stylet Versus Parker Flex-It Stylet
A study testing Glide Rite Rigid Stylet group and Parker Flex-It directional stylet group in people with Anesthesia, run by King Saud University.
Trial summary
This prospective randomized trial evaluated Parker Flex-It stylet as an alternative to manufacturer, s GlideRite® Rigid Stylet to aid intubation with the GlideScope in patients undergoing elective non-cardiac surgery that required general anesthesia with orotracheal intubation. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia
- What is being tested?
- Glide Rite Rigid Stylet group and Parker Flex-It directional stylet group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- May 2014to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- ASA physical status I\&II,
- body mass index (BMI) < 35
- elective non-cardiac surgery
- general anaesthesia with orotracheal intubation
Who cannot join
- Anticipated difficult airway,
- need for rapid sequence induction,
- ASA physical status III-V,
- increase risk of gastric aspiration such as gastro- oesophageal reflux,
- pregnancy,
- patients who had no teeth, loose teeth or oral trauma, known pathology or previous surgery to the mouth, pharynx, larynx or cervical spine and any reason why the GlideScope is not, or could not be used.
About this study
Official title: GlideRite® Rigid Stylet Versus Parker Flex-It Stylet for Orotracheal Intubation by GlideScope
This prospective randomized trial evaluated Parker Flex-It stylet as an alternative to manufacturer, s GlideRite® Rigid Stylet to aid intubation with the GlideScope in patients undergoing elective non-cardiac surgery that required general anesthesia with orotracheal intubation.
Read the detailed description
The GlideScope® Ranger (GVL; Verathon Medical Inc., Bothell, WA, USA) is a novel portable, reusable video laryngoscope that has provided superior laryngeal visualization to facilitate tracheal intubation especially in the management of difficult airways; it provides indirect visualization of the glottis with a pronounced angle of 60° in the blade. It has separate monitor connected to the handle via a cable. The tip of the blade is equipped with high-resolution digital video camera, an LED light and an antifogging system.
Unlike the Macintosh laryngoscope, an indirect laryngoscope such as the GlideScope device provides a view of the glottis without the need to align the oral pharyngeal and laryngeal axes facilitating an excellent glottic visualization. However, insertion and advancement of the endotracheal tube (ETT) may be more difficult to pass through the vocal cords than direct laryngoscopy, and trauma is possible.
The GlideScope have shown to function better when used in conjunction with use of a stylet to guide insertion of endotracheal tube. The GlideRite Rigid Stylet (GRS) is a reusable rigid steel stylet, specifically designed by the manufacturer to resemble the distal part of the GVL blade for clear view of the airway, enabling quick intubation , its curvature approaches 90° with a radius of curvature of approximately 6 cm.
Various investigators have recommended different curvatures of the ETT/stylet to optimally direct it into the trachea, including matching the blade's 60° angle, configuring the ETT with a 90° bend, or using a J-shaped ETT. Other potential strategies may include the use of a flexible stylet that allows active modification of the tip of the tracheal tube during use.
The Parker Flex-It Directional Stylet (FIS, Parker Medical, Highlands Ranch, CO) is a 2-piece plastic stylet, can be used for oral intubation, and allows continuous adjustment of the tube curvature during an intubation to enable the tube to follow the curvature of the airway. We hypothesized that the use of Parker Flex-It stylet to guide ETT might offer some benefit over the GRS.
Therefore, the purpose of this study was to determine the optimal stylet-tracheal tube strategy for use with the GlideScope® laryngoscope. We compared efficacy of the two intubating aids including GlideRite® Rigid Stylet versus Parker Flex-It stylet for orotracheal intubation in terms of the total intubation time (primary outcome), ease of intubation, the number of intubation attempts , the number of optimization man oeuvres and possible trauma (secondary outcomes) when used by experienced GlideScope operators.
- Conditions
- Anesthesia
- Being tested
- Glide Rite Rigid Stylet group, Parker Flex-It directional stylet group
- Keywords
- GlideRite, Stylet, Parker, orotracheal, intubation, GlideScope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glide Rite Rigid Stylet groupDevice
Intubation with the GlideScope® video-laryngoscope and styletted the tracheal tube using manufacturer's GlideRite Rigid Stylet (GRS) (GVL - ST1; Verathon Medical Inc., Bothell, WA, USA). Time till successful intubation of the patient is calculated.
Parker Flex-It directional stylet groupDevice
Intubated with the GlideScope® video-laryngoscope and styletted the tracheal tube using Parker-Flex-It directional Stylet (Parker Medical, Colorado, USA) (Flexi-Stylet). Time till successful intubation of the patient is calculated.
| Study group | Role | What they receive |
|---|---|---|
| Glide Rite Rigid Stylet group | Active comparator | Intubation with the GlideScope® video-laryngoscope and styletted the tracheal tube using manufacturer's GlideRite Rigid Stylet (GRS) (GVL - ST1; Verathon Medical Inc., Bothell, WA, USA). Time till successful intubation of the patient is calculated. Receives: Device: Glide Rite Rigid Stylet group |
| Parker-Flex-It Directional Stylet group | Experimental | Intubated with the GlideScope® video-laryngoscope and styletted the tracheal tube using Parker-Flex-It Directional Stylet (Parker Medical, Colorado, USA) (Flexi-Stylet). Time till successful intubation of the patient is calculated. Receives: Device: Parker Flex-It directional stylet group |
What is being measured
The primary outcome is the main question the study is designed to answer.
total intubation time
the time from insertion of the blade of the GlideScope into the oral airway to the appearance of end-tidal carbon dioxide (ETCO2) curve of at least 30 mmHg on the anesthesia monitor after insertion of the tracheal tube.
Measured: measured during intubation ( up to 120 seconds)
Secondary outcomes (1)
number of intubation attempts before successful intubation
Measured: 5minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2015 (estimated)
- Study startMay 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Saud University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ashraf Arafat Abdelhalim, King Saud University
- Investigators
- Ashraf Abdelhalim, MD, Principal investigator, King Saud University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02439606
- Sponsor's protocol ID
- E-14-1074
- Status last verified
- May 2015
- First submitted
- 1 Apr 2015
- Last updated
- 12 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GlideRite® Rigid Stylet Versus Parker Flex-It Stylet for Orotracheal Intubation by GlideScope
- ClinicalTrials.gov ID
- NCT02439606
- Acronym / sponsor ID
- E-14-1074
- Conditions
- Anesthesia
- Keywords
- GlideRite, Stylet, Parker, orotracheal, intubation, GlideScope
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- King Saud UniversityUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 12 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective randomized trial evaluated Parker Flex-It stylet as an alternative to manufacturer, s GlideRite® Rigid Stylet to aid intubation with the GlideScope in patients undergoing elective non-cardiac surgery that required general anesthesia with orotracheal intubation.
Detailed description
The GlideScope® Ranger (GVL; Verathon Medical Inc., Bothell, WA, USA) is a novel portable, reusable video laryngoscope that has provided superior laryngeal visualization to facilitate tracheal intubation especially in the management of difficult airways; it provides indirect visualization of the glottis with a pronounced angle of 60° in the blade. It has separate monitor connected to the handle via a cable. The tip of the blade is equipped with high-resolution digital video camera, an LED light and an antifogging system.
Unlike the Macintosh laryngoscope, an indirect laryngoscope such as the GlideScope device provides a view of the glottis without the need to align the oral pharyngeal and laryngeal axes facilitating an excellent glottic visualization. However, insertion and advancement of the endotracheal tube (ETT) may be more difficult to pass through the vocal cords than direct laryngoscopy, and trauma is possible.
The GlideScope have shown to function better when used in conjunction with use of a stylet to guide insertion of endotracheal tube. The GlideRite Rigid Stylet (GRS) is a reusable rigid steel stylet, specifically designed by the manufacturer to resemble the distal part of the GVL blade for clear view of the airway, enabling quick intubation , its curvature approaches 90° with a radius of curvature of approximately 6 cm.
Various investigators have recommended different curvatures of the ETT/stylet to optimally direct it into the trachea, including matching the blade's 60° angle, configuring the ETT with a 90° bend, or using a J-shaped ETT. Other potential strategies may include the use of a flexible stylet that allows active modification of the tip of the tracheal tube during use.
The Parker Flex-It Directional Stylet (FIS, Parker Medical, Highlands Ranch, CO) is a 2-piece plastic stylet, can be used for oral intubation, and allows continuous adjustment of the tube curvature during an intubation to enable the tube to follow the curvature of the airway. We hypothesized that the use of Parker Flex-It stylet to guide ETT might offer some benefit over the GRS.
Therefore, the purpose of this study was to determine the optimal stylet-tracheal tube strategy for use with the GlideScope® laryngoscope. We compared efficacy of the two intubating aids including GlideRite® Rigid Stylet versus Parker Flex-It stylet for orotracheal intubation in terms of the total intubation time (primary outcome), ease of intubation, the number of intubation attempts , the number of optimization man oeuvres and possible trauma (secondary outcomes) when used by experienced GlideScope operators.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glide Rite Rigid Stylet group | Active comparator | Device: Glide Rite Rigid Stylet groupIntubation with the GlideScope® video-laryngoscope and styletted the tracheal tube using manufacturer's GlideRite Rigid Stylet (GRS) (GVL - ST1; Verathon Medical Inc., Bothell, WA, USA). Time till successful intubation of the patient is calculated. |
| Parker-Flex-It Directional Stylet group | Experimental | Device: Parker Flex-It directional stylet groupIntubated with the GlideScope® video-laryngoscope and styletted the tracheal tube using Parker-Flex-It Directional Stylet (Parker Medical, Colorado, USA) (Flexi-Stylet). Time till successful intubation of the patient is calculated. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- ASA physical status I\&II,
- body mass index (BMI) < 35
- elective non-cardiac surgery
- general anaesthesia with orotracheal intubation
Key exclusion criteria (6 listed)
- Anticipated difficult airway,
- need for rapid sequence induction,
- ASA physical status III-V,
- increase risk of gastric aspiration such as gastro- oesophageal reflux,
- pregnancy,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glide Rite Rigid Stylet groupIntubation with the GlideScope® video-laryngoscope and styletted the tracheal tube using manufacturer's GlideRite Rigid Stylet (GRS) (GVL - ST1; Verathon Medical Inc., Bothell, WA, USA). Time till successful intubation of the patient is calculated. | Device | Glide Rite Rigid Stylet group |
| Parker Flex-It directional stylet groupIntubated with the GlideScope® video-laryngoscope and styletted the tracheal tube using Parker-Flex-It directional Stylet (Parker Medical, Colorado, USA) (Flexi-Stylet). Time till successful intubation of the patient is calculated. | Device | Parker-Flex-It Directional Stylet group |
Primary outcome
total intubation time
Time frame: measured during intubation ( up to 120 seconds)
the time from insertion of the blade of the GlideScope into the oral airway to the appearance of end-tidal carbon dioxide (ETCO2) curve of at least 30 mmHg on the anesthesia monitor after insertion of the tracheal tube.
1 secondary outcome
number of intubation attempts before successful intubation
Time frame: 5minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashraf Abdelhalim, MD principal investigator
King Saud University
Questions about this trial
What is this clinical trial studying?
A study testing Glide Rite Rigid Stylet group and Parker Flex-It directional stylet group in people with Anesthesia, run by King Saud University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
total intubation time (time frame: measured during intubation ( up to 120 seconds)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2015.